Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06194578 | A Study of Sterile Saline Infusion in Healthy Volunteers | EARLY_PHASE1 | COMPLETED | 32 | — | — | Jan 12, 2024 | Apr 23, 2024 | May 23, 2025 | 1 | United States |
Participant's pain intensity during or after the saline infusion as assessed by VAS score will be reported. VAS is a self-reported pain rating scale ranging 0=no pain to 100=worst possible pain.
Participant's pain intensity during or after the saline infusion as assessed by VPS will be reported. VPS will be graded by participants as none, mild, moderate, and severe.
| Arm | Type | Description |
|---|---|---|
| Subcutaneous Infusion of Sterile Saline | EXPERIMENTAL | Participants will receive sterile saline subcutaneous infusion administered into abdomen and/or anterior thigh through various sizes of needles at various volume and rate of delivery at Visit 1. |
| Name | Type | Description |
|---|---|---|
| Sterile Saline | OTHER | Sterile saline will be administered subcutaneously. |
Inclusion Criteria: * Body Mass Index greater than (\>)18 and less than (\<) 36 * Able to understand the English language * Has a negative coronavirus-2019 (COVID-19) test result at the time of admission, prior to administration of study intervention Exclusion Criteria: * Age \< 18 years and \> 6...